Ignite Creation Date:
2024-05-06 @ 12:02 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01479166
Status:
COMPLETED
Last Update Posted:
2014-10-29
First Post:
2011-11-22
Brief Title:
Bronchial Inflammation of Small Airways in Patients With Cystic Fibrosis
Sponsor:
Johann Wolfgang Goethe University Hospital
Organization:
Johann Wolfgang Goethe University Hospital
Study Overview
Official Title:
Bronchial Inflammation of Small Airways in Patients With Cystic Fibrosis
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRA-MUKO
Brief Summary:
In the planned study 60 patients with mild cystic fibrosis CF with and without the involvement of small airways small airway disease - SAD are to be compared with a historical control group matched in age and gender During the first study visit subjects are asked to perform a pulmonary function test spirometry body plethysmography with helium determination of Trapped Air and exhaled nitric oxide eNO and exhaled carbon monoxide eCO measurements will be done in exhaled air In addition a blood sample is drawn to describe inflammatory status Sputum is induced as well During the second study visit a non-specific bronchial provocation testmethacholine PD20 FEV1 is performed
The aim of the study is to get a characterization of the bronchial and systemic inflammation IL-1ß IL-6 IL-8 IL-17 TNF-α NFKB and recognition structures like TLR2 and TLR4 in CF patients with and without the involvement of the small airways which may point to new treatment strategies
The aim of the study is to get a characterization of the bronchial and systemic inflammation IL-1ß IL-6 IL-8 IL-17 TNF-α NFKB and recognition structures like TLR2 and TLR4 in CF patients with and without the involvement of the small airways which may point to new treatment strategies
Detailed Description:
Aim of this study is the characterization of patients with mild cystic fibrosis in terms of lung function bronchial hyperreactivity and the degree of systemic and bronchial inflammation
Sputum and serum samples are analyzed by quantitative real-time polymerase chain reactionqRT-PCR and by cytometric bead assay CBA Components of the innate immune system mannose-binding protein TLR recognition proteins and surfactant proteins are genetically determined from sputum or blood respectively In order to support the analyzed lung function and sputum serum biomarker data the investigators will also rely on pre-existing imaging data like chest x-rays or high-resolution computer tomography HRCTof the lungs
Methods and Work Programme
This study consists of two study visits V1 and V2
V1
Measurement of nitric oxide in exhaled air eNO Measurement of carbon monoxide in exhaled air eCO Lung function testing with spirometry and body plethysmography Blood test blood count CRP RAST serum inflammatory mediators genetic markers of the non-specific pulmonary defense system Induced sputum for inflammatory mediators and microbiological investigations
V2
Unspecific bronchial provocation test with methacholine PD20 FEV1 methacholine Lung function testing with spirometry and body plethysmography
Study population
CF Children and adults 6 - 60 years of age and a healthy control group 6-60 years of age Both patients and healthy subjects are recruited from the Christiane Herzog Cystic fibrosis outpatient clinic
Sputum and serum samples are analyzed by quantitative real-time polymerase chain reactionqRT-PCR and by cytometric bead assay CBA Components of the innate immune system mannose-binding protein TLR recognition proteins and surfactant proteins are genetically determined from sputum or blood respectively In order to support the analyzed lung function and sputum serum biomarker data the investigators will also rely on pre-existing imaging data like chest x-rays or high-resolution computer tomography HRCTof the lungs
Methods and Work Programme
This study consists of two study visits V1 and V2
V1
Measurement of nitric oxide in exhaled air eNO Measurement of carbon monoxide in exhaled air eCO Lung function testing with spirometry and body plethysmography Blood test blood count CRP RAST serum inflammatory mediators genetic markers of the non-specific pulmonary defense system Induced sputum for inflammatory mediators and microbiological investigations
V2
Unspecific bronchial provocation test with methacholine PD20 FEV1 methacholine Lung function testing with spirometry and body plethysmography
Study population
CF Children and adults 6 - 60 years of age and a healthy control group 6-60 years of age Both patients and healthy subjects are recruited from the Christiane Herzog Cystic fibrosis outpatient clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None